Outcomes of Biceps Tenodesis or Labral Repair for Treatment of Type 2 Superior Labrum Anterior and Posterior Lesions

NCT ID: NCT02107547

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-23
• Study Completion Date: 2017-04-11

Brief Summary

The purpose of the study is to determine which of the two alternative surgical interventions (biceps tenodesis or labrum repair surgery) is better in the treatment of Type 2 Superior Labrum Anterior and Posterior lesions.

Detailed Description

The labrum is a structure which provides stability to the shoulder joint. A superior labral tear from anterior to posterior lesion is an injury to the labrum at the insertion of the biceps muscle. The grading system is related to the severity of the tear. A type 2 tear is an intermediate grade tear. These are commonly treated in two ways: either by repairing the labrum with bone anchors or by cutting the biceps tendon and re-affixing it more distally. No method has been shown to be superior to the other and surgeons generally choose to proceed however they are most comfortable. The study will seek to determine how these injuries are best treated. Inclusion criteria: patients with type 2 superior labral tear from anterior to posterior tears who are under the age of 45. Throwing athletes are excluded due to their unique demands.

Subjects will be randomly assigned to one of two groups. Prior to surgery patients will be evaluated in clinic, full histories and physicals will be performed and their functional status will be evaluated using validated questionnaires including the American Shoulder and Elbow Society score and quality of life measurements.

Both groups will be treated first with a shoulder arthroscopy. The experimental portion of the study will involve whether the patient is then treated with repair of the Superior Labrum Anterior and Posterior lesion or with tenodesis. Repair of a Superior Labrum Anterior and Posterior lesion involves placing small anchors in the glenoid to re-attach the torn labrum. A biceps tenodesis involves cutting the tendon within the shoulder joint and reattached further down the arm. Physical therapy will be initiated after surgery and will be identical in both groups. It will be recommended but not required as part of the study. Progress notes, operative reports, and questionnaires will also be retained as part of the study. Patients will be in a sling for the first 4 weeks after surgery. Post-operatively, physical examinations findings and American Shoulder and Elbow Surgeons scores at 3, 6, and 12 months. These will be compared to the preoperative results and to the other experimental arm of the study. Post-operative imaging will not be obtained. No computerized tomographies will be required as part of the study. No Magnetic Resonance Imagings will be required as part of the study--patients enrolled in the study will likely have had an MRI performed outside of the study period to determine if they have an isolated Superior Labrum Anterior and Posterior tear but no MRIs will be performed as part of the study. No lab reports or Physical therapy reports will be included in the study.

Conditions

Type 2 SLAP Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biceps tenodesis

32 subjects in the study will receive biceps tenodesis as a surgical intervention

Group Type: ACTIVE_COMPARATOR

Biceps tenodesis

Intervention Type: PROCEDURE

A biceps tenodesis involves cutting the tendon within the shoulder joint and reattached further down the arm.

Labral repair

32 subjects in the study will receive labral repair as a surgical intervention

Group Type: ACTIVE_COMPARATOR

Labral repair

Intervention Type: PROCEDURE

Repair of a Superior Labrum Anterior and Posterior lesion involves placing small anchors in the glenoid to re-attach the torn labrum.

Interventions

Biceps tenodesis

A biceps tenodesis involves cutting the tendon within the shoulder joint and reattached further down the arm.

Intervention Type: PROCEDURE

Labral repair

Repair of a Superior Labrum Anterior and Posterior lesion involves placing small anchors in the glenoid to re-attach the torn labrum.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients with MRI diagnosed Superior Labrum Anterior and Posterior 2 lesion

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lewis L Shi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB 13-0085

Identifier Type: -

Identifier Source: org_study_id